Rapid advances in the development of cell and gene therapies over the past several years have heralded “an evolutionary time in medicine.”

That’s the opinion of Peter Walters, Director of Advanced Therapies at CRB. That thought reflects data seen in CRB’s annual Horizon Life Sciences report that highlights the rapid expansion of the development of cell and gene therapies across the industry. The data-driven CRB report finds biopharma leaders at a crossroads, facing “waves of change” in the mission to deliver lifesaving vaccines and therapies.

The Horizon report is based on survey responses from more than 500 industry leaders who provide insight into all corners of the industry. The investigation of cell and gene therapies is proving to be a disruptive space that is reshaping biopharma business models. When cell therapies first went into human testing, Walters said the big question on the minds of the scientists was, “will it work?”

“It was really a test of the science,” Walters explained. And, the science not only proved itself to be valid in the clinic, but in 2017, the U.S. Food and Drug Administration approved the first cell therapies aimed at hematologic cancers. The approval was so novel and historic that Scott Gottlieb, who served as FDA Commissioner at the time, was the one who made the public announcement heralding a new era of medicine.

“The CAR-T therapies have created a beachhead for a launch point of new companies,” Walters said, pointing to cell therapy companies such as Cabaletta Bio, Passage Bio and Century Therapeutics, Philadelphia-based cell therapy companies that launched in 2017 and beyond.

As cell therapy companies continue to push the boundaries of science and disrupt the industry overall, Walters noted that CRB’s 2021 report pinpointed a potential disruption within the cell therapy market. According to the report, nearly half of the respondents reported plans to move away from autologous cell therapies to focus on modalities with fewer challenges. Walters explained that in order to make cell therapies into a “robust scalable platform,” some of the cell therapy companies will evolve from autologous therapies to off-the-shelf modalities. He suggested that companies will take a hard look at using pluripotent stem cells that can be modified and then scaled up.

“A lot of companies are looking at allogeneic stem cells as a future-facing platform. It’s years out, but they’re looking to make this a key point in the future,” he noted.

While there is an indication that some companies intend to move away from autologous, Walters said that technology will remain in place for some time. He said that autologous cells are proven out to be more effective and longer-lasting than the allogeneic equivalents. Read More